MAUDE Adverse Event Report: MAQUET SAS HLED; LAMP, SURGICAL

Model Number ARD568320903/ARD568335999

Device Problems Peeled/Delaminated (1454); Detachment of Device or Device Component (2907)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

Additional information will be provided following the conclusion of the investigation.Device not returned to manufacturer.

Event Description

On 4th december, 2021 getinge became aware of an issues with one of surgical lights - hled.The paint peeling occurred on the spring arm of hled700 and near to the keypad on double fork.The lower rear dust cover was missing.Besides on the spring arm of hled300 the paint peeling occurred near to the keypad on double fork.We decided to report the issue in abundance of caution as any parts or particles falling off into sterile field or during procedure may cause contamination or injury.

Manufacturer Narrative

Getinge became aware of an issues with one of surgical lights - hled.The paint peeling occurred on the spring arm of hled700 and near to the keypad on double fork.The lower rear dust cover was missing.Besides on the spring arm of hled300 the paint peeling occurred near to the keypad on double fork.We decided to report the issue in abundance of caution as any parts or particles falling off into sterile field or during procedure may cause contamination or injury.It was established that when the event occurred, due to the detected paint chipping and missing dust cover the surgical light did not meet its specification and it contributed to the event.The provided information did not indicate that the device was being used for patient treatment when the event took place.During the investigation it was found that in the past the reported scenario has never lead to serious injury or worse, to death.All maquet sas products comply with: iec 60601-1 ed.2.0 & ed.3.0 general requirements for basic safety and essential performance.Iec 60601-2-41 particular requirements for the safety of surgical luminaires and luminaire for diagnosis.Paint definition pfc066.This procedure defines maquet sas¿s requirements for all painted parts.Disinfection products test: the aim of these tests is to detect any incompatibility with disinfectant.The paint chip or paint damages are due to: impacts, collisions (abnormal use).The operating manual includes the instructions to pre-position the arms prior to use, in order to prevent damages.To prevent any similar incident, it is recommended to avoid the collisions between devices.Visual inspections during the cleaning allow to detect the painting defect, we recommend to perform corrective maintenance to rectify the default after its detection.Minor pain chip can be repaired with touch up paint, nevertheless the parts impacted by serious damage must be replaced.The possible root causes of the issue with dust cover are: - non-conformity of the metal covers assembly.- degradation of the metal covers.- improper use (collision with another device) maquet sas analysis shows that the metal strip comes out of the covers when it is not clipped properly.In the scope of our continuous improvement policy, maquet sas initiated a modification file (e131106) to include this dust cover fitting procedure in the technical documentations with all spring arms.We believe that all remaining devices are performing correctly in the market.Given the circumstances and the fact that there is no apparent trend in complaints of this nature we shall continue to monitor for any further events of this nature and do not propose any further action at this time.

Event Description

Manufacturer reference number (b)(4).

• Brand Name: HLED
• Type of Device: LAMP, SURGICAL
• Manufacturer (Section D): MAQUET SAS; parc de limere; avenue de la pomme de pin; ardon
• Manufacturer (Section G): MAQUET SAS; parc de limere; avenue de la pomme de pin; ardon
• Manufacturer Contact: pascal jay ; parc de limere; avenue de la pomme de pin; ardon
• MDR Report Key: 12947337
• MDR Text Key: 282566487
• Report Number: 9710055-2021-00368
• Device Sequence Number: 1
• Product Code: FTD
• Combination Product (y/n): N
• Reporter Country Code: HK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/05/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/07/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: ARD568320903/ARD568335999
• Device Catalogue Number: ARD568320903/ARD568335999
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/15/2021
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/19/2010
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1